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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K162824
Device Name Z-Span Plate System
Applicant
Zavation, LLC
220 Lakeland Parkway
Flowood,  MS  39232
Applicant Contact Frankie Cummins
Correspondent
Zavation, LLC
220 Lakeland Parkway
Flowood,  MS  39232
Correspondent Contact Frankie Cummins
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received10/07/2016
Decision Date 02/17/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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